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Tag: Approved

  • The FDA Just Approved a Powerful Biologic for Children as Young as 6 with Severe Psoriasis or Psoriatic Arthritis

    The FDA Just Approved a Powerful Biologic for Children as Young as 6 with Severe Psoriasis or Psoriatic Arthritis

    Children as young as 6 years old with moderate-to-severe plaque psoriasis or active psoriatic arthritis now have access to one of the most effective biologics in dermatology and rheumatology, following an FDA approval announced June 26, 2026.

    AbbVie announced that the FDA has approved risankizumab (Skyrizi) for children 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for active psoriatic arthritis in the same age group. A new 55 mg prefilled syringe was simultaneously approved to support weight-based dosing for patients weighing less than 40 kg, filling a critical gap in pediatric treatment access.

    Risankizumab is now the first and only interleukin-23 (IL-23) inhibitor approved in the United States for pediatric patients 6 years of age and older who weigh less than 40 kg with either plaque psoriasis or psoriatic arthritis.

    Why This Matters

    According to Drug Topics, approximately 30 percent of people who develop psoriasis first experience symptoms before age 18. For these patients, severe psoriatic disease can mean painful, visible skin lesions that affect school participation, social development, and mental health in addition to causing physical discomfort.

    Psoriatic arthritis in children — called juvenile psoriatic arthritis or psoriatic juvenile idiopathic arthritis — causes joint pain, swelling, and stiffness that can impair a child’s ability to walk, write, or participate in normal childhood activities. Before biologics in this class were available for children, treatment options were more limited, and some children were treated off-label with adult formulations in adult doses, which is not ideal from a pharmacokinetic standpoint.

    “Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints — these conditions can shape daily life and disrupt important childhood experiences,” said Roopal Thakkar, MD, executive vice president of research and development at AbbVie.

    What We Know So Far

    Risankizumab is a humanized IgG1 monoclonal antibody that selectively blocks the p19 subunit of IL-23, a cytokine that drives the inflammatory cascade responsible for the skin plaques and joint inflammation in psoriatic disease. It was first approved for adults with moderate-to-severe plaque psoriasis in 2019 and has since received approvals for adult psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

    The pediatric approval is supported by data from the Phase 3 OptIMMize clinical trial program, which enrolled children and adolescents aged 6 through 17. Key findings from the trial:

    In adolescents aged 12 to 17: At week 16, 85.2 percent of risankizumab-treated patients achieved PASI75 (75% reduction in psoriasis severity), comparable to ustekinumab (85.7%). However, PASI100 (complete clearance) favored risankizumab at 40.7% versus 17.9% for ustekinumab.

    In children aged 6 to 11: Response rates at week 16 were high: PASI75 in 86.7%, PASI90 in 76.7%, and PASI100 (complete clearance) in 43.3%. Nearly all patients (90.0%) achieved a physician global assessment score of clear or almost clear.

    Durability: In adolescents who responded and continued treatment through week 52, approximately 95% maintained clear or almost clear skin — a strong durability finding for this age group.

    The safety profile in pediatric patients was consistent with the established adult safety profile, according to AbbVie and Contemporary Pediatrics.

    Who Qualifies for Skyrizi — Children and Dosing

    Age: 6 years and older

    Conditions: Moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; OR active psoriatic arthritis

    Dosing by weight:

    • Children weighing less than 40 kg: 55 mg subcutaneous injection (new weight-based formulation)
    • Children weighing 40 kg or more: 150 mg subcutaneous injection (same as adult dosing)

    Administration schedule: An initial dose, followed by a dose 4 weeks later, then maintenance dosing every 12 weeks thereafter — the same schedule used in adults.

    The psoriatic arthritis approval for children 6 and older is supported by the OptIMMize psoriasis data plus population pharmacokinetic modeling from well-controlled adult PsA studies.

    What Doctors and Experts Say

    Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and a lead OptIMMize study investigator, called the approval significant: “These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with these conditions.”

    Medscape’s analysis noted that this is the first IL-23 inhibitor to reach the under-40 kg pediatric population, distinguishing Skyrizi from other biologics in this class that have not yet reached this weight category in children.

    What the Evidence Shows — and What It Does Not

    MedicalDaily Evidence Check

    • Study type: Phase 3 randomized controlled trial (OptIMMize psoriasis program) — active-controlled in adolescents; single-arm open-label in children 6 to 11
    • Participants: Children and adolescents aged 6–17 with moderate-to-severe plaque psoriasis; PsA approval additionally supported by adult data plus PK modeling
    • Published in: Journal of Investigative Dermatology (conference data); FDA review completed June 26, 2026
    • What it found: High rates of PASI75, PASI90, and PASI100 at week 16 with durable responses through week 52
    • Key limitation: The psoriatic arthritis approval for children is partially supported by adult study data extrapolation through PK modeling rather than a dedicated pediatric PsA efficacy trial
    • Safety limitation noted: Detailed pediatric adverse event rates and serious adverse event rates were not publicly released in the press announcement

    What You Can Do Now

    • If your child has moderate-to-severe plaque psoriasis or psoriatic arthritis that has not been adequately controlled with topical therapies, ask your pediatric dermatologist or pediatric rheumatologist about risankizumab at your next appointment.
    • Before starting any biologic, standard screening includes tuberculosis testing, hepatitis B testing, and a review of current infections — discuss these with your child’s specialist.
    • The European Commission approved risankizumab for pediatric plaque psoriasis (ages 6 and up) on June 23, 2026 — just days before the U.S. approval — making this a global regulatory milestone for pediatric psoriatic disease.

    Cost and Access: What Patients Should Know

    Skyrizi is a biologic specialty medication. Insurance coverage and prior authorization requirements vary by plan. AbbVie has a patient support program — myAbbVie Assist — for eligible patients who need help with access or cost. Contact your specialty pharmacy or AbbVie’s patient support team for current assistance program details.

    The Bottom Line

    Skyrizi (risankizumab) is now FDA-approved for children 6 and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis — making it the first and only IL-23 inhibitor available for the under-40 kg pediatric population in the United States. Clinical trial data showed high rates of complete skin clearance in both adolescents and younger children, with durable responses through a year of treatment. Families of children with severe psoriatic disease should ask their pediatric specialist whether risankizumab is appropriate.

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  • CDC Warns Travelers Of Deadly Virus That Has No Approved Vaccines Or Treatment

    CDC Warns Travelers Of Deadly Virus That Has No Approved Vaccines Or Treatment

    The U.S. Centers for Disease Control and Prevention (CDC) has issued a health advisory warning travelers about an Ebola outbreak in Uganda caused by the deadly Sudan virus, which has no approved vaccines or treatments.

    The CDC raised the alert to Level 2, urging travelers to “Practice Enhanced Precautions,” according to a Health Alert Network advisory issued Thursday.

    The current outbreak of Sudan Virus Disease (SVD) has been reported in the Kampala, Mbale, and Wakiso regions of Uganda. Since 2000, the country has already experienced seven outbreaks of the virus.

    The first case of the current outbreak was identified after a male nurse died from the infection on January 29. A second case, identified as the wife of the index patient, has also developed symptoms and tested positive, according to a WHO weekly bulletin issued last week.

    While three of the man’s close contacts have developed symptoms and are in isolation for treatment and testing, a total of 234 contacts have been traced, including 118 linked to medical settings.

    Although there are no direct flights from Uganda to the United States, travelers from or passing through affected areas can enter the U.S. on flights connecting from other countries. Hence the CDC cautions health officials to be on alert and evaluate any patients suspected of having SVD.

    However, the CDC confirmed that “currently, no suspected, probable, or confirmed Ebola cases related to this outbreak have been reported in the United States, or outside of Uganda.”

    An initial investigation suggests the latest outbreak is not linked to the earlier outbreaks and officials suspect a new jump from animals to people.

    “The source of exposure remains unknown, raising concerns about undetected transmission chains or a new zoonotic spillover,” the WHO bulletin stated. Previous outbreaks have shown a case fatality rate ranging from 41% to 70%.

    As part of the “enhanced precautions” to reduce the risk of infection, the CDC recommends people who travel to Uganda avoid contact with sick individuals, their bodily fluids, and items they have touched, including those who have died. They are also advised to refrain from handling wild animals, visiting high-risk areas like caves or healthcare facilities in affected regions, and engaging in burial practices that involve touching the deceased.

    Travelers are asked to watch out for symptoms during the stay and three weeks after returning. Anyone experiencing symptoms is advised to isolate immediately and alert the local healthcare facility. Symptoms include fever, chills, headache, muscle aches, rash, chest pain, sore throat, nausea, vomiting and diarrhea. As the disease progresses, the patients may also develop unexplained bleeding or bruising.

    “Calling ahead before going to a healthcare facility helps the facility prepare for your arrival, including contacting health authorities and taking any precautions needed to protect staff and other patients,” the CDC said.

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